Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease

NCT03790982 | Unknown Phase 2

• 1 other identifier: AD-35-II-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Brief summary: This is a phase II study to investigate the safety, preliminary efficacy and pharmacokinetics of AD-35 tablet in patients with mild to moderate Alzheimer's Disease. This study is to be run in China involving 21 sites. It will enroll approximately 480 patients to ensure 240 randomized with mild to moderate Alzheimer's Disease. The treatment period is 52 weeks and total study duration per patient is approximately 57 weeks.

Conditions

Alzheimer's Disease

Keywords

AD-35 tablet; Alzheimer's Disease; Phase II study

Outcome Measures

Primary Outcomes (2)

• Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11 scores

  Changes in the total of ADAS-Cog11 scores of treatment compared with baseline. The score ranged from 0 to 75, and the higher the score, the greater the cognitive impairment

  Week 26

• Changes in Alzheimer's Disease Cooperative Study-clinical global impression of change (ADCS-CGIC ) scores

  Changes in ADCS-CGIC scores of treatment compared with baseline. The overall condition of the disease change is assessed (improved or deteriorated) by the doctor and the patient, and the 8-point scoring method (0-7 points) was adopted.

  Week 26

Secondary Outcomes (1)

• Changes in ADAS-Cog11 scores

  Week 6, week 13, week 39, week52

Other Outcomes (2)

• Changes in ADCS-CGIC scores

  Week 6, week 13, week 39, week52

• Changes in Mini-mental state examination (MMSE) scores

  Week 6, week 13, week 26, week 39, week52

Study Arms (4)

Placebo of AD-35 60mg /AD-35 30mg

PLACEBO COMPARATOR

Placebo of AD-35 60 mg Placebo of AD-35 30mg x two tablets, once daily in the first 26 weeks (oral), then AD-35 30mg +Placebo of AD-35 30mg, once daily in the second 26 weeks (oral)

Drug: Placebo of AD-35 60mg /AD-35 30mg

Placebo of AD-35 60mg /AD-35 60mg

PLACEBO COMPARATOR

Placebo of AD-35 60 mg Placebo of AD-35 30mg x two tablets, once daily in the first 26 weeks (oral), then AD-35 30mg x two tablets, once daily in the second 26 weeks (oral)

Drug: Placebo of AD-35 60mg /AD-35 60mg

AD-35 30 mg+Placebo of AD-35 30 mg

EXPERIMENTAL

AD-35 30 mg + Placebo of AD-35 30 mg AD-35 30 mg + Placebo of AD-35 30 mg, once daily for 52 weeks (oral)

Drug: AD-35 30 mg + Placebo of AD-35 30 mg

AD-35 60 mg

EXPERIMENTAL

AD-35 60 mg AD-35 30 mg× two tablets, once daily for 52 weeks (oral)

Drug: AD-35 60 mg

Interventions

Placebo of AD-35 60mg /AD-35 30mg DRUG

Placebo 60mg, oral, 1st 26 weeks; AD-35 30mg +Placebo of AD-35 30mg oral 2nd 26 weeks.

Also known as: Placebo of AD-35

Placebo of AD-35 60mg /AD-35 30mg

Placebo of AD-35 60mg /AD-35 60mg DRUG

Placebo 60mg, oral, 1st 26 weeks; AD-35 60mg oral, 2nd 26 weeks.

Also known as: Placebo 60mg

Placebo of AD-35 60mg /AD-35 60mg

AD-35 30 mg + Placebo of AD-35 30 mg DRUG

AD-35 30 mg + Placebo of AD-35 30 mg AD-35 30 mg + Placebo of AD-35 30 mg, Oral, 52 weeks.

Also known as: AD-35

AD-35 30 mg+Placebo of AD-35 30 mg

AD-35 60 mg DRUG

AD-35 60 mg AD-35 30 mg x two tablets, oral, 52 weeks.

Also known as: AD-35

AD-35 60 mg

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, 50-75 years of age.
• Formal education of five or more years.
• Diagnosed of probable AD in accordance with the NINCDS/ADRDA criteria (2011).
• Mild or moderate AD subjects: MMSE Score of 15-26 and CDR Score ≥ 0.5 (CDR memory score ≥ 0.5).
• Subjects must have a brain magnetic resonance imaging (MRI) scan that is consistent with a clinical diagnosis of probable AD. Brain atrophy and medial temporal lobe atrophy visual assessment scale MTA grading \>2 points. Mild white matter degeneration may occur, but Fazekas less than or equal to 2 points and supratentorial lacunar infarction lesions less than or equal to 3 points.
• The total score of modified Hachinski ischemia scale (MHIS) ≤ 4.
• Hamilton depression scale (HAMD) has a total score ≤ 17.

You may not qualify if:

• Visual, hearing and verbal communication of subjects cannot meet the needs of cognitive function evaluation.
• Inability to tolerate MRI procedures or contraindication to MRI, (such as implanted in the body, MRI incompatible pacemakers, implantable cardioverter defibrillators, cochlear implants, aneurysm clips, implanted injection pump, implanted nerve stimulator, metallic splinters in the eye, other magnetic, electrical and other metal implants) \[note\], or any other situation, in the judgment of the Investigator, is not suitable for magnetic resonance imaging (MRI).
• The investigators believe that other severe or unstable conditions may interfere with the cognitive evaluation in clinical trials.
• Dementia caused by other reasons: vascular dementia, central nervous system infection, endocrine system diseases (such as thyroid disease, parathyroid gland disease) and other reasons.

Sponsors & Collaborators

• Zhejiang Hisun Pharmaceutical Co. Ltd.: lead

Study Sites (1)

The Department of Neurosurgery

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jianping Jia, PhD

  Xuanwu hospital, capital medical university, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment, Multiple Groups, Multiple Centers

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 2, 2019
• Study Start: December 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: July 30, 2021
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

CN (1)